Observing Physiological Changes in Patients With Long-term Oxygen Therapy

Recruiting

• Conditions: Chronic Respiratory Disease

• Registration Number: NCT06525857
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

In this project, the investigators aim to assess changes of physiological parameters obtained non-invasively through PPG and accelerometry signals between before and during LTOT (long-term oxygen therapy) and investigate if those changes are different in patients with worsening frailty and/or improving quality of life.

For this, they will record optical (PPG) and accelerometry data via a datalogger on 40 patients undergoing LTOT and assess the PPG-derived physiological signals.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-01
• Study First Submitted: 2024-06-25
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-25
• Last Update Submitted: 2024-07-25
• Study First Posted: 2024-07-29
• Last Update Posted: 2024-07-29
• Primary Completion: 2025-07-01
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age ≥ 18-year-old, and
• Chronic respiratory disease including a) chronic obstructive pulmonary disease, b) interstitial lung disease, c) pulmonary hypertension, d) bronchiectasis, and
• Prescribed new LTOT due to a chronic respiratory disease with resting and/or exertional hypoxemia, and
• Able to speak/read/understand German or French, and
• Willing and able to understand and provide signed informed consent

Exclusion Criteria

• Pregnant or lactating women, or
• Inability to follow the procedures/instructions of the study (e.g. due to language, psychological disorders, dementia, etc.), or
• Patients having a subordination link to the investigators, or
• Patients with isolated nocturnal oxygen therapy or LTOT prescription for a heart disease, sleep associated breathing disorder, neuromuscular disease or lung cancer, or
• Known participation in another human research project (ClinO/HRO) that may affect the objectives of this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SpO2 changes from before and during LTOT	From 1 week before start of LTOT to 1 month after start of LTOT	Record SpO2 (%) to compare before and during LTOT
Respiratory rate changes from before and during LTOT	From 1 week before start of LTOT to 1 month after start of LTOT	Record respiratory rate (breaths per minute) to compare before and during LTOT
Heart rate changes from before and during LTOT	From 1 week before start of LTOT to 1 month after start of LTOT	Record heart rate (BPM) to compare before and during LTOT

Trial Locations

Locations (1)

Inselspital, Bern University Hospital; 🇨🇭 Bern, Switzerland